Davy James

Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.

Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer, addressing a critical unmet need with promising efficacy and improved quality of life.

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

AstraZeneca’s Farxiga has previously been approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, in addition to indications for heart failure.

Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.

This is the second accelerated approval the FDA has granted to Bristol Myers Squibb’s chimeric antigen receptor T-cell therapy in the past few months.

Ojemda is the first systemic therapy approved by the FDA for the treatment of relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation.

Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive non–small cell lung cancer.

Alvotech’s and Teva's Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis.

Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1.

The approval of AstraZeneca’s and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug's approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma.

Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy.

The FDA granted accelerated approval to Elahere in November 2022 for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously administered one to three systemic treatment regimens.

In clinical trials, the newly approved Opsynvi led to a greater drop in pulmonary vascular resistance after 16 weeks compared with both tadalafil and macitentan monotherapy.

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.

MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy.

Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.

Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg.

Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

Indication of Spevigo (spesolimab-sbzo) expanded for the treatment of generalized pustular psoriasis in patients 12 years of age and older weighing ≥40 kg.

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).

Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia.

FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

Besponsa (inotuzumab ozogamicin) was initially approved in August 2017 for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.